This is a single center,randomized ,two-cohorts, open-label ,phase 1/2 study to evaluate the efficacy and safety of T cells expressing CD19 chimeric antigen receptors treatment for relapsed/refractory CD19+ acute lymphoblastic leukemia patients.
Relapsed/refractory CD19 + acute lymphoblastic leukemia patients were randomly enrolled in this study to compare the efficacy and safety between two cohorts: 1. CD19 CAR-T cells; 2. CD19 CAR-T cells with CRS suppression technology.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Express a Second Generation 4-1BB: CD19 CAR-T cells
Express a Second Generation 4-1BB:CD19 CAR-T cells with CRS suppression technology
The first affiliated hospital of soochow university
Suzhou, Jiangsu, China
RECRUITINGIncidence of severe CRS
The safety of the CD19 CAR-T cells treatment will be evaluated and the maximum tolerated dose will be determined
Time frame: 30 days after infusion of CD19 CAR-T cells
Overall response of CD19 CAR-T cells treatment who achieve morphology complete remission(CR) and MRD negativity.
The efficacy of the CD19 CAR-T cells infusion will be estimated based on the number of participants who have morphology complete remission(CR) and MRD negativity following the CD19 CAR- T cells infusion
Time frame: 30 days after infusion of CD19 CAR-T cells
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